Z-0135-2021 Class II Ongoing
FDA device recall Z-0135-2021 was initiated by Encore Medical, LP on Sep 9, 2020 and is designated Class II. Reason for recall: Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. The recall status is ongoing. Affected quantity: 12 cups.
Recall details
- Product Type
- Devices
- Report Date
- Oct 28, 2020
- Initiation Date
- Sep 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 cups
Product description
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.
Reason for recall
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
Distribution pattern
U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
Code information
Model Number: 940-02-54G Lot Number: 801Z1036
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0135-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026